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Human Drugs

Shanghai Institute Refused FDA Inspection

FDA warns Chinas Shanghai Institute of Pharmaceutical Industry that the agency may withhold approval of ANDAs or supplements listing it as a manufactu...

Human Drugs

Edits Suggested for BEST Taxonomy

Four pharmaceutical stakeholders suggest edits to the FDA BEST glossary of biomarker, endpoints, and other tools.

Human Drugs

Complete Response Letter for AZ COPD Drug

AstraZeneca says it will work closely with FDA on next steps after receiving a complete response letter for its PT010 experimental COPD drug.

Federal Register

Fee for Tropical Disease Priority Review Voucher

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a tropical disease priority review voucher for fiscal year 2020.

Federal Register

Guide on Animal Drug Expanded Conditional Approval

Federal Register notice: FDA makes available a draft guidance for industry #261 entitled Eligibility Criteria for Expanded Conditional Approval of New...

Human Drugs

FDA/DEA Warn Online Opioid Marketers

FDA and the U.S. Drug Enforcement Administration issue joint Warning Letters to four online networks that were illegally marketing unapproved and misb...

Medical Devices

FDA Clears CivaTech Skin Cancer Patch

FDA clears a CivaTech Oncology 510(k) for its CivaDerm, a radiation therapy bandage designed for intraoperative or surface radiation to treat skin can...

Human Drugs

U.S. Specialty Formulations Cited on Inspection

FDA posts an 11-item Form FDA-483 to U.S. Specialty Formulations after concluding an inspection of its Bethlehem, PA manufacturing facility.

Human Drugs

Fee for Pediatric Priority Review Voucher

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a pediatric disease priority review voucher for fiscal year 2020.

Federal Register

Medical Countermeasure Priority Review Voucher

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a material threat medical countermeasure priority review voucher for fisca...